Exercise After Radiation for Head & Neck Cancer

NCT04013178 | Unknown

• 1 other identifier: HREBA.CC-16-0744
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

People who receive radiation therapy for head and neck cancer (HNC) can experience side-effects which include a significant loss in body mass and a loss of muscle mass (cancer cachexia). Some research has shown success in the use of generic (dynamic) resistance training interventions for patients affected by head and neck cancer. However, this approach could be optimized with the use of novel training methods.The primary aim of this research is to investigate the effect of conventional resistance training vs. an experimental intervention (electromyostimulation combined with accentuated eccentric loading) on muscle strength and muscle mass after radiation for HNC.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (2)

• Maximal Isometric Force in the Knee Extensors

  A change in maximal isometric force in the knee extensors measured before, during and after an intermittent cycling test.

  Baseline and after the 12-week intervention

• Assessment of change in Muscle Cross-Sectional Area

  ultrasound measurement of the vastus lateralis and rectus femoris

  Baseline and after the 12-week intervention

Secondary Outcomes (10)

• Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale

  Baseline to after the 12-week intervention, at 6 month and 12 month follow up

• Assessment of change in the Functional Assessment of Chronic Therapy - Head and Neck (FACT-H&N) Scale

  Baseline to after the 12-week intervention, at 6 month and 12 month follow up

• Voluntary Activation

  Baseline and after the 12-week intervention

• Potentiated Twitch Force

  Baseline and after the 12-week intervention

• Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude

  Baseline and after the 12-week intervention

Study Arms (2)

Accentuated eccentric loading + electromyostimulation

EXPERIMENTAL

This group will undertake a supervised 12-week intervention involving accentuated eccentric loading and electromyostimulation of the knee extensors, dynamic resistance training of lower limb antagonist and synergist muscles and upper limb dynamic resistance training.

Behavioral: Accentuated eccentric loading + electromyostimulation

Traditional resistance training

ACTIVE COMPARATOR

This group with undertake a supervised 12-week intervention involving volume matched dynamic resistance training of the knee extensors, and dynamic resistance training of lower limb antagonist and synergist muscles and upper limb dynamic resistance training.

Behavioral: Conventional resistance training

Interventions

Accentuated eccentric loading + electromyostimulation BEHAVIORAL

An innovative training intervention to optimize muscle strength and muscle mass

Accentuated eccentric loading + electromyostimulation

Conventional resistance training BEHAVIORAL

A conventional approach to resistance training

Traditional resistance training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a verified clinical diagnosis of head and neck cancer (stage I-IV) with the primary tumor in the oral cavity, pharynx, larynx, paranasal sinuses, or salivary glands.
• received radiation therapy ± concomitant chemotherapy
• able to walk without assistance
• received Canadian Society for Exercise Physiology-Certified Exercise Physiologist (CSEP-CEP) approval via The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and/or physician approval
• willing/able to travel to the University of Calgary (Calgary, AB).

You may not qualify if:

• comorbidities that could confound the ability to participate in laboratory tests (e.g. other malignancies, neuromuscular, musculoskeletal or vascular conditions affecting the lower extremities, such as radiculopathy or myopathy, (where the research team were consulted for individual cases)
• presence of a percutaneous endoscopic gastrostomy
• unable to follow verbal instructions in English

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Faculty of Kinesiology

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Gui Millet, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 9, 2019
• Study Start: March 31, 2017
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2020
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)